Brånemark System® 28919 (UDI 07332747159523)Recalls & reported problems

Nobel Biocare AB · Brånemark System® Mk III TiU RP 4.0x8.5mm · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Quick summary

This Nobel Biocare Brånemark System dental implant is a screw-shaped post placed in the jawbone to hold a replacement tooth. Most of the 292 reports describe the implant failing to fuse with the bone or losing its bond with the bone, and some describe infection, pain or an abscess. The reports include no deaths and 288 injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 296
Deaths reported: 0
Injuries reported: 292
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 296 adverse event reports that list this exact device (DI 07332747159523), received between Nov 1, 2021 and Sep 19, 2026 — classified as 292 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (156 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Failure to Osseointegrate156
Loss of Osseointegration108
Osseointegration Problem14
Adverse Event Without Identified Device or Use Problem10
Insufficient Device Problem Information6
Device Markings/Labelling Problem2

Patient problems

Failure of Implant184
No Clinical Signs, Symptoms or Conditions48
Unspecified Infection46
Pain28
Abscess12
Numbness8
Fistula6
Insufficient Information6

Recent adverse event reports

The 25 most recent of 296 reports, in the reporter's own words as published by the FDA.

InjurySep 19, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833302 ↗
InjurySep 19, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833296 ↗
InjurySep 9, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700316 ↗
InjurySep 9, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700304 ↗
InjuryAug 3, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50110770 ↗
InjuryAug 3, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50110769 ↗
InjuryAug 3, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Abscess
MAUDE report 50110558 ↗
InjuryAug 3, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Abscess
MAUDE report 50110557 ↗
InjuryJul 28, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50062223 ↗
InjuryJul 28, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50062222 ↗
InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50031855 ↗
InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50031854 ↗
InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50030359 ↗
InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50030358 ↗
InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50030357 ↗
InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50030356 ↗
InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Fistula
MAUDE report 50030254 ↗
InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Fistula
MAUDE report 50030253 ↗
InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50026943 ↗
InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50026850 ↗
InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50026419 ↗
InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50026418 ↗
InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50026406 ↗
InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50026405 ↗
InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50026401 ↗

Device details

UDI-DI	`07332747159523`
Brand	Brånemark System®
Model	28919
Company	Nobel Biocare AB
Product code	DZE · IMPLANT, ENDOSSEOUS, ROOT-FORM
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jul 7, 2025

Device type (GMDN): Screw endosteal dental implant, two-piece

A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
43,616 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
40,404 reports
Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
27,400 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
25,621 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
25,298 reports
Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
23,448 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
22,320 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
22,267 reports

All IMPLANT, ENDOSSEOUS, ROOT-FORM devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page